Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care

NCT04757545 | Completed DMC

• 1 other identifier: University Hospital Copenhagen
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to study the effect of a systematic approach to symptom identification and management with disease specific and clinically developed PRO (HM-PRO) with a 12 month follow up in outpatient care in patients with chronic hematological malignancy.

Conditions

Hematologic Malignancy

Keywords

HM-PRO; Symptom management; Patient reported outcome

Outcome Measures

Primary Outcomes (1)

• Change in Health related quality og life: EORTC QLQ C30

  The global health domain

  At 12 months

Secondary Outcomes (11)

• Changes in symptoms of depression and anxiety measured by HADS

  6 and 12 months

• Changes in symptom burden measured by MDASI symptom scale

  6 and 12 months

• Clinical outcomes

  At baseline

• Patient experiences measured at PREM

  6 and 12 months

• Clinical outcome

  Date for time of diagnosis - collected at baseline

Study Arms (2)

HM-PRO intervention

ACTIVE COMPARATOR

The intervention group will have a predetermined nurseled consultation planned to assess medical status and symptom control at 0, 6 and 12 months. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients.

Other: HM-PRO

Standard outpatient follow-up care

NO INTERVENTION

The control group will receive standard care in the outpatient clinic. The patient has a predetermined consultation appointment at the hospital one time a year with a doctor to evaluate medical status and symptom control.

Interventions

HM-PRO OTHER

The intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients: 1. Worsening in symptoms results in a nurse-led telephone consultation within two days guided by the symptom management manual. 2. Minor changes in patient's symptom assessment result in a nurse-led telephone consultation within seven days using the symptom management manual. 3. Patients that are completely stable in the symptom assessment will receive an electronic answer via min-SP (electronic patient journal) regarding the results and a new appointment, including PRO-data prior to this.

HM-PRO intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults \> 18 years
• diagnosed and undergoing follow up for a hematological malignancy in the outpatient clinic, Rigshospitalet
• The patients can be included approximately six months after initial diagnosis if in stable condition.
• able to manage an e-mail account

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Dept. of Hematology

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Pedersen M, Larsen MT, Kornblit BT, Dahl EO, Lomborg K, Tolver A, Jarden M. Effects of nurse-led symptom management in chronic myeloid malignancies: a randomized trial. Support Care Cancer. 2025 Feb 15;33(3):196. doi: 10.1007/s00520-025-09230-1.

  PMID: 39954038 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Maja Pedersen, Ph.d. stud.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two armed randomized controlled trial

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: February 8, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)